Blenrep (Belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple Myeloma

CAR-T Digest - August 2020

19 May 2025: Blenrep (Belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple Myeloma

GSK’s Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd) have been approved MHLW for adults with relapsed or refractory multiple myeloma
The approval is based on compelling results from the DREAMM-7 and DREAMM-8 Phase III trials, which showed notable improvements in progression-free survival and overall survival compared to standard therapies
Blenrep is the only anti-BCMA antibody-drug conjugate approved for multiple myeloma, offering a unique treatment option that does not require complex hospital-based administration
This is the second major approval for Blenrep combinations following UK MHRA approval. Reviews are ongoing in the US (PDUFA date July 23, 2025), EU, China, Canada, and Switzerland, with some receiving priority or breakthrough designations